New lupus pill shows promise in major trial

NCT ID NCT05620407

Disease control Sponsor: Bristol-Myers Squibb Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether the drug deucravacitinib can safely control symptoms in people with active moderate-to-severe lupus. About 513 participants will receive either the drug or a placebo. The goal is to see if the drug reduces lupus disease activity better than placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

513 people

The number who actually took part.

Started

Jan 2023

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria * Diagnosed with Systemic Lupus Erythematosus (SLE) at least 24 weeks before the screening visit. * Meet the European Alliance of Associations for Rheumatology (EULAR)/American College of Rheumatology (ACR) 2019 classification criteria for SLE. * One of the following: positive antinuclear antibodies (ANA) ≥ 1:80 at screening OR positive anti dsDNA OR positive anti Smith (anti Sm) as determined by the central laboratory at screening. * Total Systemic Lupus Erythematosus Disease Activity Index-2K (SLEDAI-2K) score ≥ 6 points and clinical SLEDAI 2K score ≥ 4 points with joint involvement, and/or cutaneous vasculitis, and/or rash. * Lupus headache, alopecia, organic brain syndrome, and mucosal ulcers must be recorded on SLEDAI 2K, if indicated, but do not count toward the points required for screening at entry. * At least one SLE background therapy(immunosuppressant and/or antimalarial) is required for ≥ 12 weeks before the screening visit, must be at a stable dose for ≥ 8 weeks before the screening visit, and must remain stable until randomization and throughout study participation. * Oral corticosteroid (OCS; prednisone or equivalent) background therapy is permitted but not required. For participants taking OCS, the dose must be stable for ≥ 2 weeks before the screening visit, cannot exceed 30 mg/day at screening, and must remain stable until the Week 4 visit. Participants can be on an OCS as well as an antimalarial and/or an immunosuppressant. Exclusion Criteria * Diagnosis of drug-induced SLE rather than idiopathic SLE. * Other autoimmune diseases (eg, multiple sclerosis, psoriasis, inflammatory bowel disease, etc.) are excluded. Participants with type I autoimmune diabetes mellitus, thyroid autoimmune disease, Celiac disease, or secondary Sjögren's syndrome are not excluded -SLE overlap syndromes including, but not limited to, rheumatoid arthritis, scleroderma, and mixed connective tissue disease are excluded. * Active or unstable lupus neuropsychiatric manifestations, including, but not limited to, any condition defined by BILAG A criteria. * Active, severe Class III, and IV, lupus nephritis that requires or may require treatment with cytotoxic agents or high-dose CS. * History of congenital or acquired immunodeficiency. * Known active infection, or any major episode of infection requiring hospitalization or treatment with parenteral (intramuscular or IV) antimicrobial agents (eg, antibiotics antiviral, antifungal, or antiparasitic agents) within 30 days of randomization, or treatment with oral antimicrobial agents within 2 weeks of randomization -Currently on any therapy for chronic infection (eg, pneumocystis, herpes zoster, cytomegalovirus, invasive bacterial or fungal infections, or atypical mycobacteria). * Taking more than 1 immunosuppressant at screening. * In Japan only: Participants with positive result of β - D-glucan assay. * Other protocol-defined Inclusion/Exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

autoimmune disease connective tissue disorder immune system disorder systemic lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Systemic lupus erythematosus

Contacts and locations

Locations

Emory University School of Medicine- Grady Campus

Atlanta, Georgia, 30303, United States
Local Institution - 0001

Colleyville, Texas, 76034, United States
Local Institution - 0002

Jackson, Tennessee, 38305, United States
Local Institution - 0005

Cleveland, Ohio, 44106, United States
Local Institution - 0007

Oakland Park, Florida, 33334, United States
Local Institution - 0009

León, Guanajuato, 37160, Mexico
Local Institution - 0010

Cuernavaca, Morelos, 62290, Mexico
Local Institution - 0011

Mexico City, Mexico City, 06760, Mexico
Local Institution - 0013

SAN M. de Tucuman, Tucumán Province, T4000AXL, Argentina
Local Institution - 0014

Warsaw, 00-874, Poland
Local Institution - 0016

Elblag, Warmian-Masurian Voivodeship, 82-300, Poland
Local Institution - 0017

Poznan, Greater Poland Voivodeship, 61-545, Poland
Local Institution - 0018

Quilmes, Buenos Aires F.D., 1879, Argentina
Local Institution - 0020

San Juan Bautista, Buenos Aires, 1888, Argentina
Local Institution - 0021

Sendai, Miyagi, 980-8574, Japan
Local Institution - 0022

Kawagoe, Saitama, 350-8550, Japan
Local Institution - 0023

Porto Alegre, Rio Grande do Sul, 90560032, Brazil
Local Institution - 0024

Mexico City, Mexico City, 03100, Mexico
Local Institution - 0026

Zapopan, Jalisco, 45070, Mexico
Local Institution - 0027

San Miguel de Tucumán, Tucumán Province, T4000, Argentina
Local Institution - 0028

Lajeado, Rio Grande do Sul, 95900-000, Brazil
Local Institution - 0029

Krakow, Lesser Poland Voivodeship, 30-727, Poland
Local Institution - 0031

Wroclaw, 52-416, Poland
Local Institution - 0034

Veszprém, Veszprém City, 8200, Hungary
Local Institution - 0035

Gyula, Bekes County, 5700, Hungary
Local Institution - 0036

Prague, 12850, Czechia
Local Institution - 0038

Barcelona, Barcelona [Barcelona], 08035, Spain
Local Institution - 0039

Tainan, 71004, Taiwan
Local Institution - 0040

Taichung, Taichung, 402, Taiwan
Local Institution - 0041

Skokie, Illinois, 60076, United States
Local Institution - 0043

Oklahoma City, Oklahoma, 73104, United States
Local Institution - 0045

Meguro-ku, Tokyo, 1538515, Japan
Local Institution - 0046

Bunkyo-ku, Tokyo, 1138431, Japan
Local Institution - 0047

Chiba, Chiba, 260-8712, Japan
Local Institution - 0048

Sapporo, Hokkaido, 0608648, Japan
Local Institution - 0050

Fukushima, 960-1295, Japan
Local Institution - 0051

Tokyo, 1608582, Japan
Local Institution - 0052

Seville, 41010, Spain
Local Institution - 0053

Nagoya, Aichi-ken, 457-8511, Japan
Local Institution - 0054

Tokyo, 104-8560, Japan
Local Institution - 0056

Boston, Massachusetts, 02215, United States
Local Institution - 0057

Pécs, Baranya, 7632, Hungary
Local Institution - 0058

Valencia, 46026, Spain
Local Institution - 0059

Jacksonville, Florida, 32256, United States
Local Institution - 0060

Boston, Massachusetts, 02114, United States
Local Institution - 0061

Santander, Cantabria, 39008, Spain
Local Institution - 0062

São Paulo, 01409-901, Brazil
Local Institution - 0063

La Jolla, California, 92037, United States
Local Institution - 0064

Shinjyuku-ku, Tokyo, 162-8655, Japan
Local Institution - 0065

Taichung, 404332, Taiwan
Local Institution - 0066

Maroochydore, Queensland, 4558, Australia
Local Institution - 0067

Valladolid, 47012, Spain
Local Institution - 0069

Brooklyn, New York, 11201, United States
Local Institution - 0071

Szczecin, 71-252, Poland
Local Institution - 0072

Rochester, Minnesota, 55905, United States
Local Institution - 0073

Lisbon, 2720-276, Portugal
Local Institution - 0074

Oaxaca City, 68000, Mexico
Local Institution - 0075

Margate, Florida, 33063, United States
Local Institution - 0077

Guadajalara, Jalisco, 44600, Mexico
Local Institution - 0078

Pergamino, Buenos Aires, B2700, Argentina
Local Institution - 0081

Charleston, South Carolina, 29425, United States
Local Institution - 0082

Asahikawa, Hokkaido, 0708644, Japan
Local Institution - 0083

Toyoake, Aichi-ken, 470-1192, Japan
Local Institution - 0084

Worcester, Massachusetts, 01605, United States
Local Institution - 0085

Okayama, 700-8558, Japan
Local Institution - 0086

Eiheiji-cho,Yoshida-gun, Fukui, 910-1193, Japan
Local Institution - 0087

Rio de Janeiro, 22061-080, Brazil
Local Institution - 0088

La Plata, Buenos Aires, 1900, Argentina
Local Institution - 0089

Orland Park, Illinois, 60467, United States
Local Institution - 0090

London, Greater London, SE5 9RS, United Kingdom
Local Institution - 0091

London, London, City of, SE1 9RT, United Kingdom
Local Institution - 0094

Kaohsiung Niao Sung Dist, Kaohsiung, 83301, Taiwan
Local Institution - 0101

Santiago, Santiago Metropolitan, 7500710, Chile
Local Institution - 0102

New York, New York, 10032, United States
Local Institution - 0103

Cordoba, Madrid, 14004, Spain
Local Institution - 0105

Lisbon, Lisbon District, 1649-035, Portugal
Local Institution - 0106

Chihuahua City, 31350, Mexico
Local Institution - 0107

Torreón, Coahuila, 27000, Mexico
Local Institution - 0108

Osaka, 545-8586, Japan
Local Institution - 0109

Vila Nova de Gaia, Porto District, 4434-502, Portugal
Local Institution - 0110

Bilbao, Basque Country, 48013, Spain
Local Institution - 0111

Sagamihara, Kanagawa, 252-0375, Japan
Local Institution - 0113

Sasebo, Nagasaki, 8571195, Japan
Local Institution - 0114

Taichung, 407, Taiwan
Local Institution - 0115

São Bernardo do Campo, São Paulo, 09715-090, Brazil
Local Institution - 0116

Athens, Attikí, 11527, Greece
Local Institution - 0117

Kitakyushu, Fukuoka, 807-8556, Japan
Local Institution - 0118

Lima, 15419, Peru
Local Institution - 0119

Warsaw, Masovian Voivodeship, 03-291, Poland
Local Institution - 0121

Lima, LIMA 31, Peru
Local Institution - 0122

Taipei, 11217, Taiwan
Local Institution - 0123

Athens, Attikí (Region), 115 27, Greece
Local Institution - 0124

Monterrey, Nuevo León, 64020, Mexico
Local Institution - 0125

Pilar, Buenos Aires, 1629, Argentina
Local Institution - 0126

Nagasaki, 852-8501, Japan
Local Institution - 0127

Singapore, 529889, Singapore
Local Institution - 0129

Victoria Park, Western Australia, 6100, Australia
Local Institution - 0130

Oxford, OX3 7LD, United Kingdom
Local Institution - 0131

Niigata, 951-8520, Japan
Local Institution - 0133

Danville, Virginia, 24541, United States
Local Institution - 0134

Szeged, Csongrád megye, 6725, Hungary
Local Institution - 0135

Singapore, 169608, Singapore
Local Institution - 0136

San Miguel, Buenos Aires, 1663, Argentina
Local Institution - 0137

Marietta, Georgia, 30060, United States
Local Institution - 0138

Larissa, Thessalía, 411 10, Greece
Local Institution - 0139

La Serena, Coquimbo Region, 1720430, Chile
Local Institution - 0140

Santiago, Santiago Metropolitan, 8330032, Chile
Local Institution - 0143

San Leandro, California, 94578, United States
Local Institution - 0144

Lisbon, 1050-034, Portugal
Local Institution - 0145

Syracuse, New York, 13210, United States
Local Institution - 0146

Ciudad de Buenos Aires, Buenos Aires, 1180, Argentina
Local Institution - 0147

Santa Monica, California, 90404, United States
Local Institution - 0148

Wakayama, 641-8510, Japan
Local Institution - 0150

New York, New York, 10021, United States
Local Institution - 0151

Mérida, Badajoz, 06800, Spain
Local Institution - 0152

Grand Blanc, Michigan, 48439, United States
Local Institution - 0153

Santiago, 7550000, Chile
Local Institution - 0154

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Local Institution - 0156

Nagoya, Aichi-ken, 466-8560, Japan
Local Institution - 0157

Yokohama, Kanagawa, 236-0004, Japan
Local Institution - 0158

Plovdiv, 4001, Bulgaria
Local Institution - 0159

Rousse, 7002, Bulgaria
Local Institution - 0160

Vitória, Espírito Santo, 29055450, Brazil
Local Institution - 0161

São Paulo, 01327-001, Brazil
Local Institution - 0162

Kita, Kagawa-ken, 761-0701, Japan
Local Institution - 0163

Sofia, Sofia (stolitsa), 1463, Bulgaria
Local Institution - 0164

El Paso, Texas, 79902, United States
Local Institution - 0165

Paramus, New Jersey, 07652, United States
Local Institution - 0166

Antalya, 07059, Turkey (Türkiye)
Local Institution - 0167

Gifu, 501-1112, Japan
Local Institution - 0168

Central Middlesbrough, Middlesbrough, TS4 3BW, United Kingdom
Local Institution - 0169

Katy, Texas, 77494, United States
Local Institution - 0171

Shimotsuga, Tochigi, 321-0293, Japan
Local Institution - 0173

Bunkyo-ku, Tokyo, 113-8519, Japan
Local Institution - 0174

Ostrava, Ostrava Město, 70300, Czechia
Local Institution - 0175

Barretos, São Paulo, 14784400, Brazil
Local Institution - 0176

Lima, 15072, Peru
Local Institution - 0177

Ivanhoe, Victoria, 3079, Australia
Local Institution - 0178

Charlotte, North Carolina, 28210, United States
Local Institution - 0179

Liverpool, New South Wales, 2170, Australia
Local Institution - 0181

Taipei, 10002, Taiwan
Local Institution - 0182

Parramatta, New South Wales, 2150, Australia
Local Institution - 0183

Santiago, Santiago Metropolitan, 7501126, Chile
Local Institution - 0184

Ankara, 06230, Turkey (Türkiye)
Local Institution - 0185

Warsaw, Masovian Voivodeship, 02-672, Poland
Local Institution - 0186

Lublin, Lublin Voivodeship, 20-607, Poland
Local Institution - 0187

Lodz, Łódź Voivodeship, 90-368, Poland
Local Institution - 0188

Gaziantep, 27090, Turkey (Türkiye)
Local Institution - 0190

São Paulo, 04266-010, Brazil
Local Institution - 0191

Hubli, Karnataka, 580021, India
Local Institution - 0194

San Juan, 00909, Puerto Rico
Local Institution - 0199

Secundarabad, Telangana, 500003, India
Local Institution - 0201

Temple, Texas, 76508, United States
Local Institution - 0203

Santiago, Santiago Metropolitan, 8380465, Chile
Local Institution - 0205

Pittsburgh, Pennsylvania, 15224, United States
Local Institution - 0208

Lima, 15046, Peru
Local Institution - 0210

Vellore, Tamil Nadu, 632 004, India
Local Institution - 0211

Bangkok, Bangkok, 10700, Thailand
Local Institution - 0212

Bangkok, Bangkok, 10400, Thailand
Local Institution - 0213

Clearwater, Florida, 33765, United States
Local Institution - 0216

Las Vegas, Nevada, 89102, United States
Local Institution - 0217

Great Neck, New York, 11021, United States
Local Institution - 0219

Warsaw, Masovian Voivodeship, 02-665, Poland
Local Institution - 0220

Santiago, Santiago Metropolitan, 7500571, Chile
Local Institution - 0222

Mysore, Karnataka, 570004, India
Local Institution - 0223

London, England, NW32QG, United Kingdom
Local Institution - 0224

Chorzów, Silesian Voivodeship, 41-500, Poland
Local Institution - 0225

Florence, South Carolina, 29501, United States
Local Institution - 0226

Toyoma, Toyama, 930-0194, Japan
Local Institution - 0227

Fukuoka, 812-8582, Japan
Local Institution - 0229

Nagpur, Maharashtra, 440012, India
Local Institution - 0230

Porto Velho, Rondônia, 76801-098, Brazil
Local Institution - 0231

New Orleans, Louisiana, 70112, United States
Local Institution - 0233

Ahmedabad, Gujarat, 382443, India
Local Institution - 0234

Ahmedabad, Gujarat, 380013, India
Local Institution - 0235

Hyderabad, Telangana, 500016, India
Local Institution - 0239

Plant City, Florida, 33160, United States
Local Institution - 0240

Caguas, 00725, Puerto Rico
Local Institution - 0241

La Mesa, California, 91942, United States
Local Institution - 0242

San Diego, California, 92128, United States

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